Non-Vitamin K Oral Anticoagulants (NOAC) versus Vitamin K Antagonists (VKA) for Atrial Fibrillation with Elective or Urgent Percutaneous Coronary Intervention: A Meta-Analysis with a Particular Focus on Combination Type
Abstract
:1. Introduction
2. Methods
Statistics
3. Results
3.1. Dual Antithrombotic Therapy (DAT) Consisting of a NOAC and a Single Antiplatelet Drug (SAPT: P2Y12 Inhibitor) vs. Triple Antithrombotic Therapy (TAT) Consisting of a VKA and Dual Antiplatelet Therapy (DAPT: P2Y12 Inhibitor and Aspirin)
3.2. NOAC with Any Antiplatelet Combination vs. VKA with Any Antiplatelet Combination
3.3. Subgroup Analyses
3.3.1. ISTH Major or CRNM Bleeding Events in Patients Treated with Combinations Consisting of a NOAC vs. a VKA
3.3.2. DAT vs. DAT: NOAC + P2Y12 Inhibitor vs. VKA + P2Y12 Inhibitor
3.3.3. TAT vs. TAT: NOAC + P2Y12 Inhibitor + Aspirin vs. VKA + P2Y12 Inhibitor + Aspirin
3.3.4. DAT vs. TAT: NOAC + P2Y12 Inhibitor vs. VKA + P2Y12 Inhibitor + Aspirin
3.3.5. Stent Thrombosis (ST) in Patients Treated with Combinations Consisting of NOAC vs. VKA
3.3.6. Major Adverse Cardiac Events (MACE) in Patients Treated with Combinations Consisting of NOAC vs. VKA
3.3.7. All-Cause Mortality in Patients Treated with Combinations Consisting of NOAC vs. VKA
3.4. Sensitivity Analysis
3.4.1. ISTH Major/CRNM Bleeding
3.4.2. Stent Thrombosis
4. Discussion
5. Conclusions
6. Summary Box
6.1. What Is Already Known on This Topic
6.2. What This Study Adds
Supplementary Materials
Author Contributions
Funding
Conflicts of Interest
Ethical Approval
Data Sharing
Abbreviations
Atrial fibrillation | AF |
Percutaneous coronary intervention | PCI |
Coronary artery disease | CAD |
Vitamin K antagonists | VKAs |
Non–vitamin K antagonist oral anticoagulants | NOACs |
Dual antiplatelet therapy | DAPT |
Acute coronary syndrome | ACS |
Myocardial infarction | MI |
Stent thrombosis | ST |
Triple antithrombotic therapy | TAT |
Oral anticoagulants | OAC |
Randomized controlled trials | RCTs |
Single antiplatelet therapy | SAPT |
International Society on Thrombosis and Hemostasis | ISTH |
Thrombolysis in Myocardial Infarction | TIMI |
Major adverse cardiovascular events | MACE |
Confidence interval | CI |
Dual antithrombotic therapy | DAT |
Hazard ratio | HR |
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PIONEER AF-PCI | RE-DUAL PCI | ENTRUST AF PCI | AUGUSTUS | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Rivaroxaban 15 mg QD + P2Y12 Inhibitor (N = 709) | Rivaroxaban 2.5 mg + DAPT (N = 709) | VKA + DAPT (N = 706) | Dabigatran 110 mg + P2Y12 Inhibitor (N = 981) | Dabigatran 150 mg + P2Y12 Inhibitor (N = 763) | VKA + DAPT (N = 981) | Edoxaban + P2Y12 Inhibitor (N = 751) | VKA + DAPT (N = 755) | Apixaban + P2Y12 Inhibitor (N = 2306) | VKA + P2Y12 Inhibitor (N = 2308) | Aspirin (N = 2307) | Aspirin-Matched Placebo (N = 2307) | |
Age (year) | 70.4 ± 9.1 | 70.0 ± 9.1 | 69.9 ± 8.7 | 71.5 ± 8.9 | 68.6 ± 7.7 | 71.7 ± 8.9 | 69 (63–77) | 70 (64–77) | 70.4 (64.1–77.2) | 70.9 (64.3–77.2) | 70.8 (64.4–77.3) | 70.6 (63.8–77.2) |
Female (%) | 25.5 | 24.5 | 26.6 | 25.8 | 22.4 | 23.5 | 26 | 25 | 29.1 | 28.9 | 30.2 | 27.8 |
BMI, median (IQR) | 28.6 (25.7–32.4) | 28.4 (25.6–32.1) | 29.0 (25.8–32.8) | NR | NR | NR | NR | NR | NR | NR | NR | NR |
Diabetes mellitus (%) | 28.8 | 28.1 | 31.3 | 36.9 | 34.1 | 37.9 | 34 | 34 | 36.5 | 36.2 | 36.5 | 36.2 |
Hypertension (%) | 73.3 | 73.2 | 75.4 | NR | NR | NR | 90 | 91 | 88.6 | 88.0 | 88.0 | 88.5 |
Dyslipidemia (%) | 42.6 | 41.6 | 44.8 | NR | NR | NR | 66 | 64 | NR | NR | NR | NR |
Current smoker (%) | 5.2 | 7.9 | 6.8 | NR | NR | NR | NR | NR | NR | NR | NR | NR |
History OF MI (%) | 19.8 | 25.4 | 25.4 | 24.2 | 25.4 | 27.3 | 25 | 23 | NR | NR | NR | NR |
Heart Failure (%) | 25.4 | 26.4 | 24.8 | NR | NR | NR | 56 | 54 | 42.4 | 43.2 | 42.6 | 43.0 |
History of CABG (%) | NR | NR | NR | 9.9 | 10.4 | 11.3 | 6 | 6 | NR | NR | NR | NR |
History of PCI (%) | NR | NR | NR | 33.2 | 31.3 | 35.4 | 26 | 26 | NR | NR | NR | NR |
Type of index event (%) | ||||||||||||
ACS | 51.5 | 53.2 | 52.2 | 51.9 | 51.2 | 48.4 | 52 | 52 | 61.8 | 60.5 | 60.7 | 61.7 |
NON-ACS | 48.5 | 46.8 | 47.8 | 48.1 | 48.8 | 51.6 | 48 | 48 | 38.2 | 39.5 | 39.3 | 38.3 |
Type of stent (%) | ||||||||||||
Drug-eluting | 65.4 | 66.8 | 66.5 | 82.1 | 81.5 | 84.6 | NR | NR | NR | NR | NR | NR |
Bare-metal stent | 32.6 | 31.2 | 31.8 | 15.1 | 16.1 | 13.6 | NR | NR | NR | NR | NR | NR |
Drug-eluting and bare-metal stent | 2.0 | 2.0 | 1.7 | 1.9 | 1.3 | 1.2 | NR | NR | NR | NR | NR | NR |
Type of P2Y12i (%) | ||||||||||||
Clopidogrel | 93.1 | 93.7 | 96.3 | 86.4 | 86.9 | 90.3 | 93 | 92 | 93.4 | 91.8 | 92.1 | 93.2 |
Ticagrelor | 5.2 | 4.8 | 3.0 | 12.6 | 12.1 | 7.8 | 7 | 8 | 5.4 | 7.1 | 6.5 | 5.9 |
Prasugrel | 1.7 | 1.6 | 0.7 | 0 | 0 | 0 | <1 | <1 | 1.2 | 1.1 | 1.4 | 0.9 |
Type of P2Y12i CLP/TIG/PRS | 94%/4%/1% | 88%/12%/0% | 92,5%/7,5%/<1% | 92.6%/6.2%/1.1% | ||||||||
CHA2DS2-VASc score ‡ | 3.7 ± 1.7 | 3.8 ± 1.6 | 3.8 ± 1.6 | 3.7 ± 1.6 | 3.3 ± 1.5 | 3.8 ± 1.5 | 4.0 (3.0-5.0) | 4.0 (3.0-5.0) | 3.9 ± 1.6 | 4.0 ± 1.6 | 3.9 ± 1.6 | 3.9 ± 1.6 |
HAS-BLED score † | 3.0 ± 0.91 | 2.92 ± 0.96 | 2.98 ± 0.92 | 2.7 ± 0.7 | 2.8 ± 0.8 | 2.6 ± 0.7 | 3.0 (2.0–3.0) | 3.0 (2.0–3.0) | 2.9 ± 1.0 | 2.9 ± 0.9 | 2.8 ± 0.9 | 2.9 ± 1.0 |
Trial Name | Subgroup | Anticoagulant | Duration (Months) | Patients n/N (%) |
---|---|---|---|---|
PIONEER AF-PCI | DAT | Rivaroxaban 15 mg | 12 | 709/709 (100%) |
Clopidogrel 75 mg | 12 | |||
TAT | Rivaroxaban 2.5 mg or 15 mg | 1 | 109/709 (15.4%) | |
6 | 248/709 (35%) | |||
12 | 352/709 (49.6%) | |||
ASA 75–100 mg | 12 | 709/709 (100%) | ||
Clopidogrel 75 mg | 1 | 109/709 (15.4%) | ||
6 | 248/709 (35%) | |||
12 | 352/709 (49.6%) | |||
TAT | VKA (INR 2.0–3.0) | 12 | 706/706 (100%) | |
ASA 75–100 mg | 12 | |||
Clopidogrel 75 mg | 1 | 113/697 (16.2%) | ||
6 | 243/697 (34.9%) | |||
12 | 341/697 (48.9%) | |||
RE-DUAL PCI | DAT Dabigatran 110 mg | Dabigatran 110 mg | 14 | 981/981 (100%) |
Clopidogrel 75 mg | 14 | |||
DAT Dabigatran 150 mg | Dabigatran 150 mg | 14 | 763/763 (100%) | |
Clopidogrel 75 mg | 14 | |||
TAT | VKA (INR 2.0–3.0) | 14 | 981/981 (100%) | |
ASA 75–100 mg | 1 | 171/981 (17%) | ||
3 | 810/981 (83%) | |||
Clopidogrel 75 mg | 14 | 981/981 (100%) | ||
ENTRUST AF PCI | DAT | Edoxaban 60 mg | 12 | 751/751 (100%) |
Clopidogrel 75 mg | 12 | |||
TAT | VKA (INR 2.0–3.0) | 12 | 755/755 (100%) | |
ASA 100 mg | 1 to 12 | |||
Clopidogrel 75 mg | 12 | |||
AUGUSTUS | DAT | Apixaban 5 mg | 6 | 1153/1153 (100%) |
Clopidogrel 75 mg | 6 | |||
TAT | VKA (INR 2.0–3.0) | 6 | 1154/1154 (100%) | |
ASA 81 mg | 6 | |||
Clopidogrel 75 mg | 6 |
ISTH Major/CRNM Bleeding | ||
---|---|---|
Study | RR (95% CI) for Each Study | RR (95% CI) for the Total Effect After Exclusion of Each Single Study |
AUGUSTUS: Apixaban 5mg/2.5mg | 0.39 [0.31, 0.50] | 0.71 [0.59, 0.84] |
REDUAL: Dabigatran 110mg | 0.57 [0.48, 0.68] | 0.65 [0.47, 0.89] |
PIONEER: Rivaroxaban 15/10mg | 0.66 [0.53, 0.81] | 0.62 [0.46, 0.85] |
REDUAL: Dabigatran 150mg | 0.79 [0.65, 0.95] | 0.60 [0.45, 0.80] |
ENTRUST: Edoxaban 60mg/30mg | 0.85 [0.68, 1.05] | 0.59 [0.45, 0.77] |
total | 0.63 [0.49, 0.78] | |
Stent Thrombosis (Definite or Probable) | ||
Study | RR (95% CI) | RR (95% CI) for the Total Effect After Exclusion of Each Single Study |
AUGUSTUS: Apixaban 5mg/2.5mg | 1.33 [0.46, 3.81] | 1.40 [0.83, 2.34] |
ENTRUST: Edoxaban 60mg/30mg | 1.34 [0.47, 3.84] | 1.39 [0.83, 2.33] |
PIONEER: Rivaroxaban 15/10mg | 1.25 [0.34, 4.64] | 1.40 [0.86, 2.30] |
REDUAL: Dabigatran 110mg | 1.88 [0.80, 4.40] | 1.22 [0.70, 2.11] |
REDUAL: Dabigatran 150mg | 1.00 [0.35, 2.84] | 1.50 [0.89, 2.51] |
total | 1.38 [0.87, 2.20] |
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Eyileten, C.; Postula, M.; Jakubik, D.; Toma, A.; Mirowska-Guzel, D.; Patti, G.; Renda, G.; Siller-Matula, J.M. Non-Vitamin K Oral Anticoagulants (NOAC) versus Vitamin K Antagonists (VKA) for Atrial Fibrillation with Elective or Urgent Percutaneous Coronary Intervention: A Meta-Analysis with a Particular Focus on Combination Type. J. Clin. Med. 2020, 9, 1120. https://doi.org/10.3390/jcm9041120
Eyileten C, Postula M, Jakubik D, Toma A, Mirowska-Guzel D, Patti G, Renda G, Siller-Matula JM. Non-Vitamin K Oral Anticoagulants (NOAC) versus Vitamin K Antagonists (VKA) for Atrial Fibrillation with Elective or Urgent Percutaneous Coronary Intervention: A Meta-Analysis with a Particular Focus on Combination Type. Journal of Clinical Medicine. 2020; 9(4):1120. https://doi.org/10.3390/jcm9041120
Chicago/Turabian StyleEyileten, Ceren, Marek Postula, Daniel Jakubik, Aurel Toma, Dagmara Mirowska-Guzel, Giuseppe Patti, Giulia Renda, and Jolanta M. Siller-Matula. 2020. "Non-Vitamin K Oral Anticoagulants (NOAC) versus Vitamin K Antagonists (VKA) for Atrial Fibrillation with Elective or Urgent Percutaneous Coronary Intervention: A Meta-Analysis with a Particular Focus on Combination Type" Journal of Clinical Medicine 9, no. 4: 1120. https://doi.org/10.3390/jcm9041120